On May 10, the Food and Drug Administration (FDA) authorized the Pfizer-BioNTech vaccine for emergency use in teenagers aged 12-15. This was seen by experts as a critical step to achieving herd immunity in the United States and preventing more cases and hospitalizations from the virus. Since the beginning of the vaccination campaign over 25,000 children in Kentucky aged 12-17 have gotten at least their first dose. However, some parents and teenagers are skeptical about things such as side effects and if the vaccine is effective.

On May 18, FDA Commissioner Dr. Janet Woodcock and Dr. Peter Marks, director of the Center for Biologics Evaluation and Research (the department responsible for ensuring vaccines are safe and effective), hosted an online panel for student journalists regarding Pfizer’s vaccine for 12-15 year olds. RedEye recorded some of the students’ queries and a summary of the FDA’s answers.

What was the process for testing the vaccine?

The FDA repeatedly asserts that the vaccine is safe, effective and necessary to return to normal daily life. The test group was made up of 2,000 12-15 year olds with half given a placebo made of a saline solution and the other half was given the vaccine. The tests showed the side effects were similar to those shown by adults and the immune response was just as good or better than that of adults. According to Dr. Marks, zero test subjects who received the real vaccine contracted COVID-19.

Is there a difference between the shot given to 12-15 year olds and the shot given to everyone else?

No, there is no difference. The Pfizer-BioNTech vaccine will still be a series of two doses spread two weeks apart and the same dosage will be given to 12-15 year olds as everyone else.

Many teens are willing to get the vaccine but their parents are more skeptical, how do you convince them to get the shot?

Have your parents talk to your pediatrician or family doctor about the vaccine. Often pediatricians can dispel any myths about the vaccine and help ease concerns that parents may have.

Should students who have been fully vaccinated and have waited the full two weeks to build immunity be allowed to not wear masks in school?

Masking and social distancing rules are now completely up to local communities. How many cases, the variant, and the number of vaccinated people matters in that decision and those should be taken seriously when the local governments make that decision.

In Kentucky, Governor Andy Beshear has ended the mask mandate in many indoor settings for fully vaccinated people but schools are not one of them. 

Why was the emergency use authorization only issued for 12-15 year olds and not for younger age demographics?

Testing the safety and efficacy of the vaccine on 12-15 year olds was much easier because the FDA knew that the dosage could remain the same. Because of this, the testing could begin early. Younger children require a reduced dosage and there is a possibility for a rare inflammatory syndrome after contracting the virus. The FDA has to ensure the vaccine does not cause this syndrome, so the studies took longer to set up. The results of the studies will likely come in later this year.

Would the Pfizer vaccine need a booster shot and is there a way to possibly include this in a seasonal flu shot?

The FDA anticipates that they will be able to set up studies to see if a booster shot for the vaccine could be put in the seasonal flu shot. However, they would have to be conducted quickly to line up with flu shot season in the United States. Whether or not the Pfizer-BioNTech vaccine requires a booster shot is contingent on if the first groups of immunized people still have a strong immune response or if their immune response is waning. The FDA hopes that a variant doesn’t arise that the vaccine is ineffective against, but these vaccines have such a good immune response that the current variants in the US are kept at bay by the vaccines. A booster shot may be required in a year or more.

Pfizer has previously been caught up in ethics and fraud scandals, how do you trust the efficacy of this vaccine when Pfizer has lied in the past?

While both Dr. Woodcock and Dr. Marks confirm Pfizer has done unethical things in the past (specifically surrounding the marketing of various drugs), organizations such as the FDA exist to make sure that these companies abide by regulations so that these vaccines do as intended. There are several safeguards in place, such as ensuring that submitted data matches with actual lab data, reviewing the factories where the vaccines are manufactured, and studying the vaccines after it is released.

How much did these vaccines cost and how will the United States pay for them?

The US spent close to $18 billion in vaccine development and Dr. Marks said the US is likely to spend more in regards to exporting vaccines and raw materials to other countries through direct aid and COVAX. Likely as the vaccines transition from emergency use to full authorization, more of the cost of the vaccines will be picked up by insurance. The cost of the vaccines is ultimately outweighed by the saving of human lives and the ability to return to normalcy as more people are vaccinated.